This guidance provides information for firms about how FDA evaluates firms’ medical product communications that fall within the scope of FDA’s regulatory authority (product communications) and that present information not contained in the FDA-required labeling for the product but that may be consistent with the FDA-required labeling for the product. For the purposes of this guidance and as further explained in section III, information that is consistent with the FDA-required labeling is limited to information about the approved or cleared uses of a product. The term FDA-required labeling as used in this guidance includes the labeling reviewed and approved by FDA as part of the medical product marketing application review process. For products not subject to premarket approval, but instead subject to premarket notification (510(k)) requirements or exempt from premarket review, the term FDA-required labeling includes the labeling that provides adequate directions for use and other information required to appear on the label or in labeling.
FDA is providing this guidance to address frequently asked questions concerning this topic.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.